FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇷 Türkiye
STONELITH, MODEL V5
K Number: K011106
·
Decision Feb 11, 2002
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
55
Applicant Total
2
Review Days
306
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Basic Information
- Device Name
- STONELITH, MODEL V5
- K Number
- K011106
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5990
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pck Electronic Industry and Trade Co, Ltd.
- Date Received
- April 11, 2001
- Decision Date
- February 11, 2002
- Product Code
- LNS
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LNS | Lithotriptor, Extracorporeal Shock-Wave, Urological | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Pck Electronic Industry and Trade Co, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K011311 | UROLOGIC | Jul 10, 2001 | Substantially Equivalent |